Abstract: Objective Aim To analyze clinical characteristics of drug-induced liver injury (DILI).Methods Clinical data of 116 patients with DILI in Zhongshan Hospital Affiliated to Fudan University were retrospectively collected from November 2016 to November 2019.Clinical characteristics were analyzed.The continuous data were expressed as median and interquartile range M(P25-P75),and the Mann-Whitney U test was used for comparison between groups.The chi-square test was used for comparison of categorical data between groups.Results Among all 116 patients,there were 69 female patients and most of the patients were aged 40-69 years.Of all patients,23 cases were induced by Western medicine,82 cases had DILI induced by Chinese herbal medicine and healthcare products,11cases may caused by Chinese herbal medicine and Western medicine.The most commonly implicated Chinese herbal medicines were compound preparations or decoctions containing Panax pseudo-ginseng or Radix polygoni multiflori.The most commonly causative Western medicines were antimicrobial agents and non-steroidal anti-inflammatory drugs.The median time from taking medications to the onset of symptoms were 28 days.70.7% cases were presented with hepatocellular injury type.The patients with liver injury induced by Chinese herbal medicine had significantly higher on admission values of ALT,AST and γ-GT than those with liver injury induced by Western medicine (all P<0.05).Liver biopsy was performed in 9 cases,whereas all pathological findings prompted diagnosis of DILI.Only one patient displayed combination with auto immune hepatitis in pathological presentation.Biopsy ratio was significantly different in different clinical classification,while biopsy ratio was highest in mixed type.Fourty-four patients treated with glucocorticoid had higher on admission levels of TBil,DBil,ALP and lower serum albumin than those without glucocorticoid treatment.Of all patients,94.8% of them achieved improvement,and patients with poor responses to treatment had higher values of TBil,DBil,INR and lower serum albumin than patients with good prognosis (all P<0.05).Conclusion DILI is commonly observed in female middle-aged and elderly patients.The most causative drugs were Chinese herbal medicines.The major type of DILI was hepatocellular injury.Liver biopsy was not required for the diagnosis of DILI in our setting.Most DILI patients have good prognosis.

Key words: drug-induced liver injury, clinical feature